New research indicates that the Ortho Evra birth-control patch can significantly increase the risk of stroke for young women. Johnson and Johnson has placed a new warning on the packaging and is supposedly considering a recall. If you or your wife are using the patch, you'll probably want to talk to your doctor (or your lawyer, since there are certain to be lawsuits filed and awards handed out).
Thursday's warning comes four months after reports that patch users die and suffer blood clots at a rate three times higher than women taking the pill.
Citing federal death and injury reports, The Associated Press found that about a dozen women, most in their late teens and early 20s, died in 2004 from blood clots believed to be related to the birth-control patch, and dozens more survived strokes and other clot-related problems.
20-year-old women shouldn't be having strokes, and a 300% increase is huge. As much as I dislike the FDA, there often doesn't appear to be much incentive for drug companies to be honest in their dealings with the public.
In addition, an internal Ortho McNeil memo shows that the company refused, in 2003, to fund a study comparing its Ortho Evra patch to its Ortho-Cyclen pill because of concerns there was "too high a chance that study may not produce a positive result for Evra" and there was a "risk that Ortho Evra may be the same or worse than Ortho-Cyclen."
Last week, in response to questions about the Ortho McNeil memo, company spokesman Michael Beckerich said in a written statement that "decisions to fund studies are based upon scientific merit."
Drug companies should be required to release such information to the public, but once the truth is known the FDA shouldn't prevent people from taking risky drugs if they want to. In many cases, risky drugs can save more lives than over-protective government policy.